Friday, April 10, 2009

Vaccinating against cervical cancer - medicolegal and ethical considerations of off-label use

There has been quite a bit of publicity about the issue of cervical cancer vaccinations, especially the application of this vaccine to older women. Today's Straits Times carried an article by Huang Huifern about this, and the forum page carried a letter from GSK Biologicals.

Here's my take on this.... and some words of caution ...

Firstly the public should be aware that regulatory authorities everywhere in the world approve medicines and their specific usage based on all available evidence submitted by the manufacturer with respect to efficacy and safety. The FDA does it, and so does the HSA in Singapore. As I understand it, based on existing evidence with respect to efficacy and safety, the approval in Singapore is only for females between 9-26 years. Now you may quibble about the quality of the decision, but for better or worse, the best available scientific evidence as evaluated by our regulatory authorities, is just that.

The approval does not mean it is illegal to use the vaccine in other situations. Such use is referred to as 'off-label' use of the drug. Both doctors and patients should however, be aware that such use is entirely at the risk appetite of the doctor who recommends it and the acceptance of the patient. No vaccine is entirely safe, and there are valid suspicions that the vaccines in question may produce serious though rare side effects.

A discussion of off-label use of drugs can be found here. While it applies largely to a US situation, it does give an insight into the ethics and medico-legal aspects of the off-label use. Some people regard it as a form of experimentation, since the use of the drug is being used in a manner that has not been approved or validated. As such, the off-label use of the drug should be reviewed by an ethics committee.

The medico-legal aspects also need to be considered. By using the vaccine in an unapproved context, the doctor exposes himself to a substantial medico-legal liability. If serious side effects occur and it can be shown that the doctor did not appropriately advise the patient of such risks or lack of efficacy data, he of course, opens himself to a law suit.

Lastly, the promotional activities of the manufacturer should be consistent with only the approved used of the medication. In the US, pharma companies have been taken to task for promoting the off-label use of drugs. I am not aware if there have been such precedences in Singapore, and would appreciate legal opinions about this here; but we should clearly be wary when manufacturers hype up their products so that it practically encourages and sanctions off-label use.

I hope this posting may provoke the legal eagles in cyberspace and regulators in HSA to respond in some way or other, and bring clarity to this issue.